Neoadjuvant Weekly Paclitaxel and Biomarkers of Therapy Response
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Infusions
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Paclitaxel will be initiated as standard infusions on days 1, 8, and 15 of a 21-day cycle."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether paclitaxel, a cancer drug, increases damage to chromosomes inside tumor cells and kills tumors that already have this damage. It is for women with breast cancer that has not spread to distant parts of the body. Patients get weekly drug infusions at outpatient visits for four treatment cycles before surgery.
The hypothesis of this study is that paclitaxel levels increase chromosomal instability (CIN) in tumors and this is lethal to tumors that have pre-existing CIN. Treatment will be administered on an outpatient basis. Paclitaxel will be initiated as standard infusions on days 1, 8, and 15 of a 21-day cycle. Participants will continue with paclitaxel for cycles 2-4 prior to surgery.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Women with breast cancer confirmed by testing a tissue sample, with no cancer spread to distant parts of the body.
- Your cancer doctor must agree that paclitaxel before surgery is right for you. You cannot receive other cancer treatments at the same time.
- A stored tumor tissue block or at least 8 unstained slides from an earlier breast tumor or lymph node biopsy must be available.
- Your breast tumor or lymph node must be easy to reach for a biopsy, and you must agree to another biopsy to remove a tissue sample.
- Your breast tumor must be measurable on a scan before treatment. The same type of scan must be repeated after four treatment cycles, before surgery.
- You must not have had chemotherapy that treats the whole body for your current breast cancer. Some studies not meant to treat the cancer are allowed.
- Your organs and bone marrow, which makes blood cells, must work well enough, as judged by your cancer doctor.
- You must be able and willing to sign a consent form. If you could become pregnant, you must agree to use effective birth control during the study.
Who can't join
- Past allergic reactions to drugs similar to paclitaxel, including drugs made with Cremophor EL, a form of castor oil.
- Known HIV infection, because chemotherapy may further weaken your ability to fight infections.
- Taking blood thinners other than aspirin, such as Coumadin, heparin, or clopidogrel, or having a known bleeding disorder.
- An uncontrolled illness, such as a severe infection, heart failure with symptoms, unstable chest pain, an abnormal heartbeat, or another cancer needing treatment.
- A mental health condition or life situation that your doctor believes would keep you from following study requirements.
- Pregnancy. If you are breastfeeding, you must stop to join the study.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Women with pathologically demonstrated breast cancer * Patients must be candidates for neoadjuvant paclitaxel chemotherapy by their treating oncologist. No other investigational or commercial therapeutic agents may be given concurrently with the paclitaxel. * Patients must not have metastatic disease on staging work-up per institutional guidelines. * A formalin-fixed paraffin embedded tumor block (preferred) or unstained slides must be available from a prior biopsy of the primary tumor (preferred) or lymph node. A minimum of 8 slides must be available. * The primary tumor or lymph node must be readily biopsied by surgery or radiology teams. * The primary tumor must be measurable by an imaging modality prior to treatment. This imaging modality is to be repeated after completion of 4 cycles of paclitaxel and prior to surgery. Such imaging modalities may include ultrasound, CT, mammography, or MRI. MRI will be the preferred imaging modality if available because it has the highest accuracy and positive predictive value for predicting pathologic complete response.All imaging will be performed per standard of care at the discretion of the treating physicians. * Subjects may not have had prior systemic chemotherapy regimens administered for treatment of their current breast cancer. However, studies (window studies, for example) that are deemed non-therapeutic, including those that utilize agents that are not FDA approved for the treatment of the patient's current breast cancer, are permitted. * Patients must have adequate organ and marrow function as determined by the treating oncologist. * Patient must be willing to undergo additional biopsy of breast tumor or lymph node. * Patient must have the ability and willingness to sign a written informed consent document. * Women of childbearing potential (per institutional policy) must agree to use effective contraception as discussed with treating oncologist for the duration of the study. Exclusion Criteria: * History of allergic reactions attributed to compounds of similar chemical or biologic composition to paclitaxel including to other drugs formulated in Cremophor(R) EL (polyoxyethylated castor oil). * Patients with known HIV due to concern that chemotherapy may cause further immunosuppression and potential infectious complications. * Patients on non-aspirin anti-coagulation (Coumadin, heparins, or clopidogrel) or with documented bleeding disorders will be excluded due to risk of bleeding with biopsy. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active severe infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, other malignancies requiring therapy or psychiatric illness/social situations that would limit compliance with study requirements as determined by treatment physician. * Pregnant women are excluded from this study because paclitaxel is a pregnancy category D drug and may cause deleterious effects to the fetus. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with paclitaxel, breastfeeding should be discontinued if the mother is enrolled in the trial.
Study sites (2)
IA
- University of Iowa Health Care/Holden Comprehensive Cancer Center · Iowa City, IA 52242Mark Burkard, MD, PhD · Principal investigatorMore trials in Iowa City
WI
- University of Wisconsin Carbone Cancer Center · Madison, WI 53792Cancer Connect · Study contact · 800-622-8922 · clinicaltrials@cancer.wisc.eduMore trials in Madison